ट्रायल रडार AI | ||
|---|---|---|
क्लिनिकल ट्रायल NCT04225572 के लिए स्तन कैंसर वर्तमान में सक्रिय, भर्ती नहीं है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
Physical Rehabilitation Evaluation and Optimal Physical Therapy (PRE-OPT)
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'परीक्षण समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल परीक्षण NCT04225572 एक हस्तक्रियात्मक चिकित्सकीय अध्ययन है जो स्तन कैंसर से जुड़ा हुआ है। परीक्षण वर्तमान में सक्रिय, भर्ती नहीं चल रहा है। इसकी शुरुआत 27 दिसंबर 2017 को हुई थी, और इसमें कुल 135 प्रतिभागियों के नामांकन की योजना है। Masonic Cancer Center, University of Minnesota इस परीक्षण का नेतृत्व कर रहे हैं और इसके 1 दिसंबर 2026 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 6 जनवरी 2025 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
Phase 1: The investigators will conduct a prospective study to quantify the association between axillary web syndrome (AWS) and metastatic disease and chronic morbidities such as lymphedema, shoulder dysfunction, and pain comparing women (i) with AWS and (ii) without AWS in two cohorts of women. (n=200) Phase 2: This is a randomized controlled trial to 1) quantify the effects of (i) physical therapy compared to (ii) a control group in individuals with AWS following breast cancer surgery related to physical activity and physical impairments such as lymphedema, shoulder motion, function, and pain (n=44, 22 in each group). Funding to progress to Phase 2 of this trial has been obtained. It is anticipated 120 subjects participating in Phase 1 will be screened for eligibility for Phase 2 (separate consent and eligibility from Phase 1).
आधिकारिक शीर्षक
Physical Rehabilitation Evaluation and Optimal Physical Therapy (PRE-OPT)
चिकित्सीय स्थितियाँ
स्तन कैंसरअन्य अध्ययन आईडी
- 2017NTLS119
- PMR-2017-26231 (अन्य पहचानकर्ता) (University of Minnesota Masonic Cancer Center)
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2017-12-27
अंतिम अद्यतन प्रकाशित
2025-01-06
अध्ययन की समाप्ति तिथि (अनुमानित)
2026-12
नामांकन (अनुमानित)
135
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
निर्दिष्ट नहीं
स्थिति
सक्रिय, भर्ती नहीं
प्राथमिक उद्देश्य
सहायक देखभाल
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
एकल अंध
समूह/हस्तक्षेप
| प्रतिभागी समूह/हाथ | हस्तक्षेप/इलाज |
|---|---|
कोई हस्तक्षेप नहींControl Group Patient will not receive physical therapy treatment or further instruction from the research team. The patient will receive standard care recommended by their medical provider which may or may not include physical therapy treatment. | निर्दिष्ट नहीं |
प्रयोगात्मकPhysical Therapy Group | Physical Therapy: Dependent on Patient's Needs Therapeutic exercise:
* ROM: Begin with passive upper extremity ROM and progress to active ROM.
* Strengthening: Progressive upper extremity resistive exercises starting with light weights.
* Aerobic: Select a suitable, individual aerobic exercise program (walking, yoga, etc.) Manual therapy
* Soft tissue mobilization, myofascial release, and stretching of identified tight and stiff tissue.
Lymphedema treatment
* Manual lymph drainage: Gentle lymphatic massage to lymph nodes and vessels by PT for 1-2 weeks. Instruct patient in self MLD to perform 1-2×/day for 10 minutes during the remaining weeks.
* Compression therapy: Gradient compression bandaging for daily wear with activities and exercise for 1-2 weeks. Instruct in self compression bandaging or issue a compression garment to wear with exercise or activity, or with worsening symptoms of AWS (i.e. cording extends down arm) or lymphedema. |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Clinical characteristics of preoperative Auxillary Web Syndrome (AWS) | Status of lymph nodes in women who have preoperative AWS (lymph node metastasis present or not) | 1 Year |
Treatment Effects | Range of motion (ROM) will be measured using a standard goniometer | 1 Year |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Pain level | Measured by 0-10 scale and Penn Shoulder Score questionaire | 1 Year |
Function | Disabilities of the Arm, Shoulder and Hand questionaire | 1 Year |
Lymphedema | Measured by girth measures, tissue dielectic constant and bioimpedance spectroscopy | 1 Year |
Physical activity | Measured by International Physical Activity Questionaire IPAQ (short form) | 1 Year |
Axillary web syndrome status | (present/not present) based on palpable assessment by investigator | 1 Year |
Preoperative AWS and a positive lymph node status | Correlation between AWS and a positive lymph node status | 1 Year |
Abduction range of motion (ROM) | ROM measured by a standard goniometer | 1 month |
DASH Score | Measured by Disabilities of the Arm, Shoulder, and Hand questionnaire | 1 Month |
Body mass index (BMI) | Difference in body mass index (BMI) between patients with and without AWS (pre and post operative) | 1 month |
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी
- Age ≥ 18
- Patients (female or male) with a tissue diagnosis of non-invasive or invasive breast cancer
- Planned surgical breast cancer treatment (lumpectomy or mastectomy) with a minimum removal of one axillary lymph node by sentinel node biopsy. Contralateral prophylactic mastectomy or bilateral mastectomy is allowed.
- Voluntary written consent signed before performance of any study-related procedure not part of normal medical care
- Patients (patients unable to travel easily to the University of Minnesota Medical Center for post-surgery visits).
- Synchronous bilateral breast cancer
- Presence of a medical complication that would prevent the patient from being able to participate in the study, such as terminal cancer
- Previous history of upper extremity deep vein thrombosis
- Breast cancer surgery without lymph node removal
Masonic Cancer Center, University of Minnesotaकोई संपर्क डेटा नहीं।
1 1 देशों में अध्ययन स्थल
Minnesota
University of Minnesota Masonic Cancer Center, Minneapolis, Minnesota, 55455, United States